MAUDE Adverse Event Report: COCHLEAR LTD NUCLEUS CI512 COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CI512

Device Problem No Device Output (1435)

Patient Problem Failure of Implant (1924)

Event Date 10/21/2020

Event Type  Injury  

Event Description

Per the clinic, the patient experienced a loss of sound on (b)(6) 2020, and subsequent loss of connection to the internal device.Troubleshooting attempts were made; however, the issue could not be resolved.It is unknown if there are plans to explant the device and to reimplant the patient with a new device as of the date of this report.

Manufacturer Narrative

This report is submitted on 1 march 2021.

Event Description

It was reported that the device was explanted on (b)(6) 2021, and the patient was re-implanted with a new device during the same surgery.

• Brand Name: NUCLEUS CI512 COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE
• Type of Device: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LTD; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• MDR Report Key: 10872002
• MDR Text Key: 217306203
• Report Number: 6000034-2020-03168
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502014564
• UDI-Public: (01)09321502014564(11)110801(17)130731
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date: 03/01/2021,02/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2013
• Device Model Number: CI512
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/01/2021
• Distributor Facility Aware Date: 02/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 10 YR